The Fast-track Centre for Hip and Knee Replacement Database

Patient Satisfaction Clinical Trial

— FCD  

Official title:

The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613439
• Other study ID #: FC-1
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2022
• Source: Rigshospitalet, Denmark
• Contact: Christoffer C Jorgensen, M.D.
• Phone: +48 29 66 59
• Email: christoffer.calov.joergensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective study-registry on preoperative patient characteristics and postoperative complications in patients having fast-track hip and knee replacement surgery in 8 Danish dedicated arthroplasty departments from all five health regions in Denmark. The registry consists of detailed patient and physician reported preoperative characteristics and including prescribed medication and lab results. Follow-up is based on electronical medical records by dedicated nurses with physician backup and includes Clavien-Dindo and Comprehensive Complication Index scoring. All patients having day-surgery also completes a patient reported questionaire on health-care utilization and return to work by day 30. Finally, a machine-learning algorithm for identification of "high-risk" patients based on he preoperative data is included.

Description:

The study registry is intended for further detailed research on postoperative morbidity, feasibility and safety of day surgery and functional outcomes after fast-track hip and knee replacement in 8 dedicated Danish arthroplasty wards across all five health care regions in Denmark. The work is a continuation of the Lundbeck Foundation Centre Database on Hip and Knee Replacement also registered in ClinicalTrials but ceased enrolling in august 2017. The aim of the registry is to provide standardized and comprehensive information on preoperative patient characteristics and postoperative complications, patient reported outcome measures and health-care utilization in fast-track hip and knee replacement within a socialized health-care system. Each department have dedicated research personel assuring registration and follow-up supervised by a datamanager, and with database-support from the Danish health Region of Southern Denmark. All departments have similar established fast-track protocols as standard of care, but with focus on dividing patients into day-surgery, main fast-track group and high-risk cohorts. Preoperative data includes information on prescribed medication, Clinical Frailty Score using CFS v.1, evaluation of Pain Catastrophizing Scale as well as laboratory testing of hemoglobin, kidney function, Hb1Ac in diabetics and C-reactive protein level. On the basis of the collected preoperative data a machine-learning algorithm for identifying the "high-risk" patients is being refined and with planned induction in the database.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age >18 years
• non-malignant surgery
• danish social security number
• elective procedure

Exclusion Criteria:

• unwilling to provide informed consent

Related Conditions & MeSH terms

• Ambulatory Surgical Procedures
• Enhanced Recovery After Surgery
• Fast-track Surgery
• Hip
• Knee
• Patient Satisfaction
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• Day-surgery
Standard surgical procedure but with planned discharge on day of surgery
• High-risk patient
Standard fast-track procedure but with additional perioperative measures dependent on risk-profile.
• Main Group
Standard fast-track procedure according to usual standard of care and discharge when fulfilling functional discharge criteria

Locations

Country	Name	City	State
Denmark	Bispebjerg University Hospital	Copenhagen	Capital Region
Denmark	Aalborg University Hospital, Farsø	Farsø	Region Of Northern Judland
Denmark	Gentofte University Hospital	Gentofte	Capital Region
Denmark	Gødstrup Hospital	Herning	Region Of Middle Judland
Denmark	Hvidovre Hospital	Hvidovre	Capital Region
Denmark	Næstved Hospital	Næstved	Region Seeland
Denmark	University Hospital Svendborg	Svendborg	Region Of Southern Denmark
Denmark	Lillebaelt Hospital, Vejle	Vejle	Region Of Sourthern Denmark

Sponsors (11)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg University Hospital, Bispebjerg Hospital, Gødstrup Hospital, Hvidovre University Hospital, Naestved Hospital, Region of Southern Denmark, Svendborg Hospital, Sygehus Lillebaelt, The Novo Nordic Foundation, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	return to work in day-surgery	changes in work status and time to return to work in day-surgery procedures	30 days postoperatively
Other	patient satisfaction and patient reported outcome measures1	collection of data on patient satisfaction and function after surgery using the EQ-5D-5L (score from 0-100 with increasing score indicating better health)	Baseline, 90 and 365 days postoperatively
Other	patient satisfaction and patient reported outcome measures, THA only.	collection of data on patient satisfaction and function after surgery using the Oxford Hip Score (range from 0-48 with increasing score indicating better function).	Baseline, 90 and 365 days postoperatively
Other	patient satisfaction and patient reported outcome measures, TKA only.	collection of data on patient satisfaction and function after surgery using the Oxford Knee score (range from 0-48 with increasing score indicating better function).	Baseline, 90 and 365 days postoperatively
Primary	Fraction of unselected patients able to undergo day-surgery procedures	The fraction patients eligible for day-surgery who are discharged on day of surgery.	7 days postoperatively
Primary	postoperative morbidity	postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery.	90 days postoperatively
Primary	postoperative morbidity Clavien-Dindo	Postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Clavien-Dindo index.	90 days postoperatively
Primary	postoperative morbidity CCI	Postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Comprehensive Complication Index	90 days postoperatively
Secondary	Healthcare utilisation in day-surgery	Registration of emergency room visits, visits to general practitioners and use of medical emergency services within 30 days after having hip or knee replacement as day-surgery procedure.	30 days postoperatively